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NCT04068181 · ClinicalTrials.gov registry record · Phase 2
Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT04068181 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 72 participants.
The verdict
NCT04068181, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.
Interventions
- DRUG Pembrolizumab
- DRUG Talimogene laherparepvec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-01-22 |
| Est. Completion | 2024-02-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04068181
The ClinicalTrials.gov registry entry for NCT04068181 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04068181 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04068181 about?
NCT04068181 is a clinical study titled "Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).". This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic me...
What is the current status of trial NCT04068181?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2020-01-22. Estimated completion is 2024-02-26.
What interventions are being tested in trial NCT04068181?
The interventions under investigation include: Pembrolizumab (DRUG), Talimogene laherparepvec (DRUG).
Who is sponsoring clinical trial NCT04068181?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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